Recruiting

Mesh

Sponsor:

UCLA

Code:

NCT05190978

Conditions

Breast Cancer

Breast Implant; Complications, Infection or Inflammation

Eligibility Criteria

Sex: Female

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Acellular Dermal Matrix

Reconstruction without ADM

Study Details

Brief summary:

Surgical mesh products, particularly acellular dermal matrices (ADM), are now used by the majority of plastic surgeons to assist with the nearly 100,000 prosthetic breast reconstruction procedures in the United States, despite never being approved by Food and Drug Administration (FDA) for this indication. As surgeons transition to placing breast implants above the chest muscle (pre-pectoral), there has been an increasing reliance on these often expensive mesh products without robust evidence to understand their risks and benefits. Our pilot study is a randomized multi-center trial to evaluate surgical mesh assistance in pre-pectoral tissue expander to breast implant reconstruction to address vital questions for women's public health.

Conditions

Breast Cancer

Breast Implant; Complications, Infection or Inflammation

Study ID

NCT05190978

Start date

Oct 20, 2022

Status verified date

Apr, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female patients age 22 to 75 undergoing unilateral or bilateral immediate pre-pectoral reconstruction with tissue expanders
  • Prophylactic and oncologic mastectomies are both acceptable
  • Nipple sparing and skin sparing mastectomy techniques are both acceptable

Exclusion Criteria:

  • Intraoperative assessment demonstrates unfavorable conditions (ie poor mastectomy skin flap thickness or viability) for immediate pre-pectoral reconstruction in any breast
  • Bilateral reconstruction patients undergoing contralateral submuscular reconstruction
  • Direct-to-implant reconstruction
  • Pregnancy
  • Delayed reconstruction

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acellular Dermal Matrix

Patients will receive ADM during their initial tissue expander placement.

active comparator: Control

Patients will not receive ADM during their initial tissue expander placement.

Interventions

Acellular Dermal Matrix

Acellular dermal matrix will surgically implanted around the tissue expanders in patients in the ADM cohort.

Reconstruction without ADM

Acellular dermal matrix will not be surgically implanted around the tissue expanders in patients in the control cohort.

Primary outcome measure

  • Safety - Major Complications [ Time Frame: 2 years ]
  • Effectiveness - BREASTQ [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Michael Delong, MD

(310) 825-5510mdelong@mednet.ucla.edu

Jaco Festekjian, MD

(310) 825-5510

Locations

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Michael Delong, MD

310 825 5510mdelong@Mednet.ucla.edu

Jaco Festekjian, MD

310 825 5510

Principal Investigator:

Michael DeLong, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • breast cancer
  • breast reconstruction
  • breast implant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-05-05.